Vardenafil Hydrochloride

Product NDC: 71335-9689
11-digit product format: 713359689
Labeler code: 71335
Product ID: 71335-9689_834cdc21-877d-4687-b9e8-4d418702f261
Type: HUMAN PRESCRIPTION DRUG
Nonproprietary name: Vardenafil Hydrochloride
Dosage form: TABLET
Route: ORAL
Labeler: Bryant Ranch Prepack
Application: ANDA209057
Marketing category: ANDA
Marketing start: 2018-11-01
Substance: VARDENAFIL HYDROCHLORIDE
Active strength: 20 mg/1
Pharmacologic classes: Phosphodiesterase 5 Inhibitor [EPC], Phosphodiesterase 5 Inhibitors [MoA]
NDC exclude flag: No
Listing certified through: 2026-12-31
Current FDA listing: Yes

openFDA Listing Details

Product ID: 71335-9689_834cdc21-877d-4687-b9e8-4d418702f261
Product type: HUMAN PRESCRIPTION DRUG
Finished product: Yes
Brand name base: Vardenafil Hydrochloride
Generic name: Vardenafil Hydrochloride
Dosage form: TABLET
Route: ORAL
Marketing start: 2018-11-01
Marketing category: ANDA
Application number: ANDA209057
Pharmacologic classes: Phosphodiesterase 5 Inhibitor [EPC]; Phosphodiesterase 5 Inhibitors [MoA]
Listing expiration: 2026-12-31

Ingredient	Strength
VARDENAFIL HYDROCHLORIDE	20 mg/1

UNII	Preferred term	Registry number	Matched term
5M8S2CU0TS	VARDENAFIL HYDROCHLORIDE	330808-88-3	VARDENAFIL HYDROCHLORIDE

Package NDC	11-digit format	Description	Units	Marketing start	Sample	Exclude flag	Status
71335-9689-1	71335968901	30 TABLET in 1 BOTTLE (71335-9689-1)	30 tablet	2023-04-06	No	No	Current

Title	Manufacturer	Effective date	Type	Version
Vardenafil Hydrochloride	Bryant Ranch Prepack	2025-10-28	HUMAN PRESCRIPTION DRUG LABEL	103